CA3069155A1 - Sterilisation par rayonnement de formes posologiques de polymere hypercomprimees - Google Patents

Sterilisation par rayonnement de formes posologiques de polymere hypercomprimees Download PDF

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Publication number
CA3069155A1
CA3069155A1 CA3069155A CA3069155A CA3069155A1 CA 3069155 A1 CA3069155 A1 CA 3069155A1 CA 3069155 A CA3069155 A CA 3069155A CA 3069155 A CA3069155 A CA 3069155A CA 3069155 A1 CA3069155 A1 CA 3069155A1
Authority
CA
Canada
Prior art keywords
dosage form
lactide
polymer
sterile
glycolide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3069155A
Other languages
English (en)
Inventor
Barry M. Libin
Jeffrey M. Liebmann
Weiliam Chen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SUSTAINED NANO SYSTEMS LLC
Original Assignee
SUSTAINED NANO SYSTEMS LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SUSTAINED NANO SYSTEMS LLC filed Critical SUSTAINED NANO SYSTEMS LLC
Publication of CA3069155A1 publication Critical patent/CA3069155A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A61K9/204—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029—Radiation
    • A61L2/007—Particle radiation, e.g. electron-beam, alpha or beta radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/087—Particle radiation, e.g. electron-beam, alpha or beta radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

La présente invention concerne une forme pharmaceutique stérile qui comprend un polymère de lactide à coiffe d'ester, un polymère de glycolide ou un copolymère lactide-glycolide hypercomprimé avec un composant pharmaceutique actif, ladite forme pharmaceutique stérile ayant été stérilisée avec un faisceau d'électrons et un procédé de préparation de ladite forme pharmaceutique stérile.
CA3069155A 2017-07-11 2018-07-10 Sterilisation par rayonnement de formes posologiques de polymere hypercomprimees Pending CA3069155A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762531239P 2017-07-11 2017-07-11
US62/531,239 2017-07-11
PCT/US2018/041511 WO2019014269A1 (fr) 2017-07-11 2018-07-10 Stérilisation par rayonnement de formes posologiques de polymère hypercomprimées

Publications (1)

Publication Number Publication Date
CA3069155A1 true CA3069155A1 (fr) 2019-01-17

Family

ID=65000465

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3069155A Pending CA3069155A1 (fr) 2017-07-11 2018-07-10 Sterilisation par rayonnement de formes posologiques de polymere hypercomprimees

Country Status (10)

Country Link
US (2) US10500163B2 (fr)
EP (1) EP3651771B1 (fr)
JP (1) JP7357367B2 (fr)
CN (1) CN111032054A (fr)
AU (1) AU2018300071A1 (fr)
BR (1) BR112020000504A2 (fr)
CA (1) CA3069155A1 (fr)
IL (1) IL271904B2 (fr)
MX (1) MX2020000377A (fr)
WO (1) WO2019014269A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11458041B2 (en) 2015-10-08 2022-10-04 Ocular Therapeutix, Inc. Punctal plug and bioadhesives
MX2020000377A (es) * 2017-07-11 2020-07-14 Sustained Nano Systems Llc Esterilizacion mediante radiacion de formas de dosis de polimero hipercomprimido.
ES2952213T3 (es) 2020-02-06 2023-10-30 Ocular Therapeutix Inc Composiciones y métodos para tratar enfermedades oculares

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5899411A (ja) 1981-12-05 1983-06-13 Shoichiro Ozaki 制ガン剤
CH679207A5 (fr) 1989-07-28 1992-01-15 Debiopharm Sa
FR2756493B1 (fr) * 1996-12-02 2001-04-13 Delab Dispositif d'administration locale de formulations solides ou semi-solides
US20020111603A1 (en) 1996-12-02 2002-08-15 Societe De Conseils De Recherches Et D'application Device for local administration of solid or semi-solid formulations and delayed-release formulations for proposal parental administration and preparation process
DE19856432A1 (de) 1998-12-08 2000-06-15 Basf Ag Nanopartikuläre Kern-Schale Systeme sowie deren Verwendung in pharmazeutischen und kosmetischen Zubereitungen
MXPA04011801A (es) 2002-05-31 2005-09-12 Desitin Arzneimittel Gmbh Composicion farmaceutica que contiene oxcarbazepina con liberacion controlada de la substancia activa.
WO2004085523A1 (fr) 2003-03-27 2004-10-07 Jsr Corporation Moulage de resine et article travaille obtenu a partir de celui-ci
JP4475891B2 (ja) 2003-06-20 2010-06-09 ホソカワミクロン株式会社 経肺製剤の製造方法
WO2005110374A1 (fr) * 2004-04-30 2005-11-24 Allergan, Inc. Systemes de distribution de medicaments intraoculaires contenant un agent therapeutique, une cyclodextrine et un composant polymere
US7203263B2 (en) * 2004-07-26 2007-04-10 General Electric Company Core spray apparatus and method for installing the same
EP1786400B1 (fr) 2004-08-12 2009-03-11 Quest Pharmaceutical Services Compositions pharmaceutiques permettant la liberation progressive de composes bioactifs
FR2880273B1 (fr) 2004-12-30 2007-03-30 Ceva Sante Animale Sa Procede de separation d'une composition pharmaceutique solide a liberation prolongee et controlee sous hautes pressions
US20090082321A1 (en) 2007-09-21 2009-03-26 Allergan, Inc. Steroid containing drug delivery systems
JP2008051144A (ja) 2006-08-22 2008-03-06 Kayaba Ind Co Ltd 車両用ブレーキ装置
CA2704111C (fr) * 2007-05-14 2017-06-20 Sustained Nano Systems Llc Particules hypercomprimees pour liberation controlee de medicaments ophtalmiques
US20090148498A1 (en) * 2007-05-14 2009-06-11 Sustained Nano Systems Llc Controlled release implantable dispensing device and method
KR100873700B1 (ko) 2007-06-25 2008-12-12 사단법인 한국가속기 및 플라즈마 연구협회 전자빔을 이용한 바이오 연료 제조 방법
JP2012524779A (ja) * 2009-04-23 2012-10-18 サステインド ナノ システムズ リミテッド ライアビリティ カンパニー 制御放出分配デバイス
CN106178015A (zh) 2010-03-26 2016-12-07 3M创新有限公司 消毒伤口敷料的方法
CA2954170A1 (fr) * 2014-07-03 2016-01-07 Otonomy, Inc. Sterilisation d'une composition de ciprofloxacine
US10780099B2 (en) * 2015-10-16 2020-09-22 Marinus Pharmaceuticals, Inc. Injectable neurosteroid formulations containing nanoparticles
MX2020000377A (es) * 2017-07-11 2020-07-14 Sustained Nano Systems Llc Esterilizacion mediante radiacion de formas de dosis de polimero hipercomprimido.
JP2020531571A (ja) * 2017-07-11 2020-11-05 サステインドナノシステムズエルエルシーＳｕｓｔａｉｎｅｄ Ｎａｎｏ Ｓｙｓｔｅｍｓ Ｌｌｃ 超圧縮医薬製剤

Also Published As

Publication number Publication date
EP3651771B1 (fr) 2023-08-30
EP3651771A4 (fr) 2021-03-31
AU2018300071A1 (en) 2020-02-13
CN111032054A (zh) 2020-04-17
EP3651771A1 (fr) 2020-05-20
US10500163B2 (en) 2019-12-10
US10744099B2 (en) 2020-08-18
EP3651771C0 (fr) 2023-08-30
JP2020531570A (ja) 2020-11-05
US20200085755A1 (en) 2020-03-19
US20190015347A1 (en) 2019-01-17
IL271904B2 (en) 2023-06-01
JP7357367B2 (ja) 2023-10-06
MX2020000377A (es) 2020-07-14
BR112020000504A2 (pt) 2020-07-14
IL271904A (en) 2020-02-27
WO2019014269A1 (fr) 2019-01-17

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